Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
6. oktober 2020 oppdatert av: Qing Shu, Wuhan University
Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial
Patients who underwent modified radical mastectomy were enrolled in the study.
200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group.
The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed.
The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430070
- Zhongnan Hospital of Wuhan University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Between the ages of 25 and 75 years;
- Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
- Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
- Postoperative chemotherapy or radiation therapy according to the condition;
- No other malignant tumors within 5 years;
- No physical therapy related contraindications;
- Signing informed consent.
Exclusion Criteria:
- The result of SLNB is negative who did not receive ALND;
- Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
- Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
- Combined severe heart disease, cerebrovascular disease, and mental illness;
- Patients with shoulder joint dysfunction before surgery;
- Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 7 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
Eksperimentell: 7 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
Eksperimentell: 3 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
Eksperimentell: 3 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Constant-Murley Shoulder Score
Tidsramme: 1 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
1 weeks after surgery
|
|
Constant-Murley Shoulder Score
Tidsramme: 3 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
3 weeks after surgery
|
|
Constant-Murley Shoulder Score
Tidsramme: 6 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
6 weeks after surgery
|
|
Constant-Murley Shoulder Score
Tidsramme: 9 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
9 weeks after surgery
|
|
Constant-Murley Shoulder Score
Tidsramme: 12 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
12 weeks after surgery
|
|
Constant-Murley Shoulder Score
Tidsramme: 18 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
18 weeks after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Active and passive range of motion
Tidsramme: 3 days，1, 2, 3, 6, and 9 weeks after surgery
|
In the standard position, the mobility of the shoulder flexion, extension, external rotation and internal rotation was measured by using protractor.
The range of flexion is 0-180°, the range of extension is 0-180°, the range of external rotation is 0-90°, and the range of internal rotation is measured.
0-70°.
The assessments will be performed in the active and passive state separately.
|
3 days，1, 2, 3, 6, and 9 weeks after surgery
|
|
Shoulder joint muscle strength
Tidsramme: 3 days, 3, 6, 9 weeks after surgery
|
In the standard position, the muscle strength of the flexion, extension, external rotation and internal rotation of the shoulder joint were assessed according to the "manual muscle test standard".
|
3 days, 3, 6, 9 weeks after surgery
|
|
The power of gripping
Tidsramme: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
|
In the standard position, the grip of the patient's palm is measured using a dynamometer.
|
1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
|
|
EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
Tidsramme: 1, 3, 9, 12, 18 weeks after surgery
|
The quality of life assessment of breast cancer patients was evaluated by the total score of the EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire, which ranged from 0 to 92.
Higher scores indicate better quality of life.
|
1, 3, 9, 12, 18 weeks after surgery
|
|
SF-36 Health status questionnaire
Tidsramme: 1, 3, 9, 12, 18 weeks after surgery
|
The quality of life assessment of breast cancer patients was evaluated by the total score of the SF-36 Health status questionnaire, which ranged from 0 to 92.
Higher scores indicate better quality of life.
|
1, 3, 9, 12, 18 weeks after surgery
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale （VAS)
Tidsramme: 1 day, 3 days, 1 week, 2 weeks after surgery
|
Visual Analogue Scale（VAS): Used to assess the degree of pain.
Draw a 10 cm horizontal line on the paper.
One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates different degrees of pain.
|
1 day, 3 days, 1 week, 2 weeks after surgery
|
|
Sum drainage from chest wall and axillary after operation.
Tidsramme: 1 day, 3 days, 1 week, 2 weeks after surgery
|
The postoperative drainage was the total volume of the chest wall drainage tube and the underarm drainage tube.
The volume measurement and recording in the drainage bag were observed daily by the nurse.
|
1 day, 3 days, 1 week, 2 weeks after surgery
|
|
Upper limb circumference
Tidsramme: Preoperative 3, 9, 12,18 weeks after surgery
|
Preoperative 3, 9, 12,18 weeks after surgery
|
|
|
body weight
Tidsramme: Preoperative, 3, 9 weeks after surgery
|
Preoperative, 3, 9 weeks after surgery
|
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. september 2018
Primær fullføring (Faktiske)
31. mai 2020
Studiet fullført (Faktiske)
31. mai 2020
Datoer for studieregistrering
Først innsendt
29. august 2018
Først innsendt som oppfylte QC-kriteriene
31. august 2018
Først lagt ut (Faktiske)
5. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRE2018013
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.
IPD-delingstidsramme
About six months after the trial complete
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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